Myovant Sciences: Progress in Women's Health

Myovant Sciences (MYOV) released data from the LIBERTY-2 trial, the company’s second of two identical Phase III trials investigating relugolix+ABT in patients with heavy menstrual bleeding associated with uterine fibroids, explains John McCamant, editor of the Medical Technology Stock Letter.

Data from the trial were similar when compared with the previously disclosed results from the LIBERTY-1 study as LIBERTY-2 also met the primary endpoint by statistically significantly increasing the rate of patients responding to therapy as compared to placebo.

In the study 71.2% of patients receiving relugolix+ABT responded to therapy as compared to only 14.7% in the placebo arm (p<0.0001).

This data is quite similar to that seen in LIBERTY-1 where 73.4% and 18.9% of patients in the active and placebo groups responded to treatment. Most importantly, the second positive Phase IIII trial positions Myovant to file an NDA submission by the end of 2019.

A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method.

In addition, a significantly greater proportion of women suffering from moderate-to-severe pain from uterine fibroids at baseline experienced no pain or minimal pain during the last 35 days of treatment with relugolix combination therapy compared with women on placebo (p < 0.0001).

The drug candidate was safe with the overall incidence of adverse events in the relugolix combination and placebo groups was almost the same (60.3% vs. 58.9%).

The stock continues to languish despite delivering undeniably positive Phase III trials which position the company to file for FDA approval by year end.

Myovant also disclosed that data from their bioequivalence study comparing a single co-formulated tablet to the co-adminsitered regimen tested in the LIBERTY studies met all 16 endpoints that the FDA had requested.

The company plans to leverage these data as part of their submission to the FDA in hopes of gaining approval for a single tablet regimen.

Filings for approval of the single as a treatment for pain related to uterine fibroids are expected to be completed in the US and EU in 4Q19 and 1Q20. Lastly, the company said data from the HERO trial in patients with prostate cancer will be available in Q4:19. A

dditionally, management also guided that data from the SPIRIT 1 and SPIRIT 2 studies of relugolix+ABT in patients with endometriosis-associated pain will be available in Q1:20 and Q2:20.

In our view, LIBERTY-2 has significantly de-risked the stock and opens the door for either a partnership or a takeout as the drug candidate has a high chance of receiving FDA approval. The stock is a buy under $17 with a target price of $25.